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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-11-29

RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-411/1011/1-8/TL/16
2. Name of Authorisation Holder	:	Sanofi Pasteur Sp. z o.o.
3. Address(es) of Site(s)	:	Ul. Stefana Batorego 1, Pass, Blonie, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Bonifraterska 17, Warszawa, mazowieckie, 00-203, Poland
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2016-08-17
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Sanofi Pasteur Sp. z o.o.

(ORG-100037101 / LOC-100070434)

, Ul. Stefana Batorego 1, Pass, Blonie, 05-870, Poland

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Hurtownia prowadzi obrót produktami leczniczymi, dla których podmiotami odpowiedzialnymi są:
1.Sanofi Pasteur S.A.
2.Sanofi Pasteur Europe

Reason for Withdrawing:

Zezwolenie wygaszone z dniem 11.08.2024/WDA withdrawn on 11 August 2024

Union Format for a Wholesale Distribution Authorisation	GIF-N-411/1011/1-8/TL/16
	Page 1

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